Package Labeling:

SPL v1

SPL

SPL Set ID 52f03bbe-76a3-43fb-b64f-e3e81f9e0558

Route

TOPICAL

Published

Effective Date 2018-05-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging

Description

Homosalate 2% Avobenzone 8% Octocrylene 5.5% Octisalate 2%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

• Helps prevent sunburn.

Dosage and Administration

• Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months: Ask a doctor.

Description

Homosalate 2% Avobenzone 8% Octocrylene 5.5% Octisalate 2%

Section 42229-5

• Protect from excessive heat and direct sun.

Section 50565-1

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

if rash occurs.

Section 50567-7

keep out of eyes. Rinse with water to remove.

Section 50570-1

on damaged or broken skin.

Section 51727-6

Mineral Oil, Beeswax(Cera Alba), Cera Microcristallina, Ozokerite, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridecyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.

Section 51945-4

Label2

Section 53413-1

Call AP Specialties

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 2% Avobenzone 8% Octocrylene 5.5% Octisalate 2%

Structured Label Content

Indications and Usage (34067-9)

• Helps prevent sunburn.

Dosage and Administration (34068-7)

• Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months: Ask a doctor.

Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

• Protect from excessive heat and direct sun.

Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

if rash occurs.

Section 50567-7 (50567-7)

keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

on damaged or broken skin.

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Label2

Section 53413-1 (53413-1)

Call AP Specialties

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 2% Avobenzone 8% Octocrylene 5.5% Octisalate 2%

Raw Label Data

All Sections (JSON)

{"34067-9": "• Helps prevent sunburn.", "34068-7": "• Apply liberally 15 minutes before sun exposure. • Use a water resistant sunscreen if swimming or sweating. • Reapply at least every 2 hours. • Children under 6 months: Ask a doctor.", "34071-1": "For external use only.", "42229-5": "• Protect from excessive heat and direct sun.", "50565-1": "If product is swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "if rash occurs.", "50567-7": "keep out of eyes. Rinse with water to remove.", "50570-1": "on damaged or broken skin.", "51727-6": "Mineral Oil, Beeswax(Cera Alba), Cera Microcristallina, Ozokerite, Polyisobutene, Cocos Nucifera (Coconut) Oil, Ethylhexyl Palmitate, Polyethylene, Tridecyl Trimellitate, Butyrospermum Parkii (Shea Butter), BHT, Tocopheryl Acetate, Fragrance.", "51945-4": "Label2", "53413-1": "Call AP Specialties", "55105-1": "Sunscreen", "55106-9": "Homosalate 2% Avobenzone 8% Octocrylene 5.5% Octisalate 2%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:34.809635 · Updated: 2026-02-15T11:56:34.767364